NCT05426239

Brief Summary

This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

June 16, 2022

Last Update Submit

June 16, 2022

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Up to a maximum of 4 years of follow-up

Secondary Outcomes (9)

  • Progression-Free Survival (PFS)

    Up to a maximum of 4 years of follow-up

  • Objective Response Rate (ORR)

    Up to a maximum of 4 years of follow-up

  • Duration of Response (DOR)

    Up to a maximum of 4 years of follow-up

  • Treatment-free Interval (TFI)

    Up to a maximum of 4 years of follow-up

  • Treatment-free Survival (TFS)

    Up to a maximum of 4 years of follow-up

  • +4 more secondary outcomes

Study Arms (1)

Cohort 1

Participants initiating first-line systemic therapy to treat advanced melanoma.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult participants diagnosed with advanced melanoma in the ADOReg database. Participants were included based on the following: * a diagnosis of advanced (unresectable or metastasized) melanoma at stage III or IV according to American Joint Committee on Cancer or AJCC staging * Participants receive systemic therapy to treat the advanced melanoma * First-line treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

You may qualify if:

  • Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV
  • Participants received any systemic therapy to treat the advanced melanoma
  • First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)

You may not qualify if:

  • Age \<18 years at index date
  • Receipt of clinical trial study drug at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site0001

Frankfurt, 60549, Germany

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 21, 2022

Study Start

January 9, 2019

Primary Completion

September 7, 2020

Study Completion

September 7, 2020

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

DE(1)